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EdgeTemp Hydraulic Temporary Restorative

EDGE ENDO LLC · Model EETEMP · UDI-DI 00818365020027

EBG Prescription

510(k) clearances

122

Adverse events (1 deaths)

Recalls

184

Facilities

Description

For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for installation. Intended to restore carious lesions or structural defects in teeth temporarily. Intended for use in cavities Classes I, II, III, IV (inlays and onlays) and as a restorative material for veneers, crowns and bridges.

Recalls

Date	Firm	Reason
2020-10-09	Talladium Inc	Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (
2009-10-22	Jeneric/Pentron	Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in
2004-06-07	Lang Dental Mfg Co, Inc.	The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
2004-06-07	Lang Dental Mfg Co, Inc.	The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.